AIM: To study the relative bioavailability of
potassium clavulanate and amoxicillin dispersible tablet in 10 healthy male
Chinese volunteers. METHODS: According to the crossover design, each volunteer was given a single oral dose of 625 mg test tablet and reference tablet. The serum concentrations of
potassium clavulanate and amoxicillin were determined by
high performance liquid chromatography(HPLC). Pharmacokinetic paramters were calculated. The analysis of variance and two one side t test were used to evaluate the variance between 2 groups. RESULTS: For a single dose test tablets, the AUC 0→t , c max , t max , T 1/2 of potassium clavulanate and amoxicillin were (3 18±1 58) h·μg·mL -1 ,(1 50±0 90) μg·mL -1 ,(1 33±0 59) h,(1 02±0 34) h and (13 66±1 16) h·μg·mL -1 ,(6 55±1 46) μg·mL -1 ,(1 03±0 42) h,(1 15±0 32) h, respectively. The reference tablets were (2.76±0 84) h·μg·mL -1 , (1 32±0 47) μg·mL -1 ,(1 53±0 71) h,(1 28±0 51) h and (11 03±1 53) h·μg·mL -1 ,(5 08±1 28) μg·mL -1 ,(1 05±0 26) h,(1 04±0 47) h, respectively. The relative bioavailability of potassium clavulanate and amoxicillin of test tablets were 112 80% and 126 14%, respectively. All pharmacokinetic parameters of potassium clavulanate had no significant difference between 2 preparations, but the AUC 0→8 and c max of amoxicillin of test tablets were significantly higher than that of reference tablets. CONCLUSION: The 2 preparations are not bioequivalent. The test tablets have higher bioavailability than that of the reference tablets.